(100 days)
the Crono Five and Crono PCA 50 has been designed for use in subcutaneous, intravenous, epidural and intrathecal infusions of prescribed liquid medicines.
Crono Five is a new, innovative ambulatory infusion pump that is very appreciated by health care professionals and patients due to its small size and technical features. Crono Five is especially suited for controlled drug administration on patients in hospital or undergoing a therapy at home. The pump is suitable for subcutaneous, intra-venous, epidural and intrathecal infusions allowing 4 different administration modalities: 1. Continuous 2. Bolus dose upon request (PCA) 3. Clinician bolus (managed by clinician) 4. Combined (continuous + bolus upon request + clinician bolus). Crono Five pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. The pump is provided with key-pad lock-out functions in order to avoid un-authorized reprogramming of the drug administration protocol. The liquid crystal display (LCD) can show relevant information to caregivers and patients like programmed values, amount of drug delivered, remaining delivery time etc. Crono PCA 50 is essentially the same as the Crono Five, but has a 50 ml infusion capacity.
The provided text describes the 510(k) premarket notification for the Crono Five and Crono PCA 50 ambulatory infusion pumps. However, it does not contain the level of detail typically found in a study that proves a device meets specific acceptance criteria, especially for AI/ML-driven devices.
Based on the information provided, here's an attempt to answer the questions, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table between the new devices (Crono Five and Crono PCA 50) and a predicate device (Crono PCA - K013822; though Crono go - K013840 is listed under physical characteristics). While this table shows performance characteristics, it doesn't explicitly state "acceptance criteria" against which these performances are measured in a quantifiable sense, beyond general equivalence.
| Characteristic | Crono PCA - K013822 (Predicate Device) | Crono Five / Crono PCA 50 (New Device) | Acceptance Criteria (Implied) | Reported Performance (New Device) |
|---|---|---|---|---|
| Intended Use | subcutaneous, intra-venous, epidural and intrathecal infusions of prescribed liquid medicines. | SAME | Be equivalent to predicate | Same as predicate |
| Physical characteristics | Crono go - K013840 (for size/weight) | Crono Five / Crono PCA 50 | Be equivalent to predicate | Crono Five: 77x48x29 mm, 115g. Crono PCA 50: 84.5x55x42 mm, 140g. (Size and Weight vary from "SAME" for Crono Five and Crono PCA 50, but are considered acceptable in the context of similarity to Crono go) |
| Size | 3" x 1.85" x 1.14" (77 x 48 x 29 mm) | SAME (for Crono Five); 84.5 x 55 x 42 mm (for Crono PCA 50) | Be comparable to predicate | Crono Five: 77x48x29 mm. Crono PCA 50: 84.5x55x42 mm. |
| Weight | 4.0 oz (115 g) (battery included) | SAME (for Crono Five); 140 g (battery included) (for Crono PCA 50) | Be comparable to predicate | Crono Five: 115g. Crono PCA 50: 140g. |
| Battery | Power Source Lithium battery (3V) of the 123 A type. | SAME | Be equivalent to predicate | Same as predicate |
| Infusion per impulse | 22 μl. | Crono Five: 5 μl. Crono PCA 50: 20 μl. | Achieve intended infusion rates and volume with sufficient precision | Crono Five: 5 μl. Crono PCA 50: 20 μl. (These are different but considered acceptable for purpose.) |
| Flow rate accuracy | +/-2%. | Crono Five: +/-2%. Crono PCA 50: +/-3%. | Maintain acceptable flow rate accuracy for intended use | Crono Five: +/-2%. Crono PCA 50: +/-3%. |
| Max. Occlusion pressure | 4.5 bar +/-1 bar. | Crono Five: 2.2 bar +/-0.5 bar. Crono PCA 50: 2.2 bar +/- 0.5 bar. | Have an appropriate safety margin for occlusion pressure | Crono Five: 2.2 bar +/-0.5 bar. Crono PCA 50: 2.2 bar +/- 0.5 bar. (Different but presumably within safe operating limits). |
| Capacity | 10 or 20 ml. | 10, 20 ml or 50 ml. | Meet desired capacity range | 10, 20 ml or 50 ml. |
The primary "acceptance criterion" articulated is "Substantial Equivalence" to the legally marketed predicate device (Crono, K041414). The study (as described) aims to demonstrate that the new device is "as safe and effective" as the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "bench, EMC, and user testing." It does not specify the sample size for these tests (e.g., number of devices tested, number of users involved). The provenance of the data is not explicitly stated beyond the fact that the company (Canė S.r.l.) is based in Italy. It's not clear if the user testing was prospective or retrospective; bench and EMC testing are generally prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The context of this device (infusion pump) suggests that "ground truth" would be established through engineering specifications, calibration standards, and clinical performance assessments rather than expert interpretation of medical images or data. There's no indication of experts in the sense of medical diagnosticians establishing ground truth. "User testing" would involve healthcare professionals, but their number and specific qualifications for establishing ground truth are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of this device (an infusion pump) and the type of testing mentioned (bench, EMC, user testing), an "adjudication method" in the context of expert consensus for diagnostic interpretation is not applicable. Testing would likely involve adherence to engineering standards and verification procedures.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI/ML diagnostic or image analysis tools where human readers’ performance is being evaluated with and without AI assistance. The Crono Five and Crono PCA 50 are infusion pumps, not AI/ML diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an infusion pump, which is a hardware device with embedded software for controlling the infusion process. It's not an AI/ML algorithm in the context of standalone diagnostic performance. The "bench testing" would represent the standalone performance of the device against its specifications, but not in the sense of an algorithm operating without human intervention for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an infusion pump, the "ground truth" for performance characteristics (like flow rate accuracy, infusion per impulse, occlusion pressure) would be established by:
- Engineering specifications and standards: Adherence to defined physical and performance parameters, often verified with calibrated equipment.
- Bench testing: Measuring actual output against expected output using precise instrumentation.
- User feedback/testing: Verifying that the device operates as intended in a clinical or simulated clinical environment and meets user requirements for usability and safety.
There is no mention of expert consensus, pathology, or outcomes data in the sense of a medical diagnostic study.
8. The sample size for the training set
This information is not applicable as the device is not described as an AI/ML system that undergoes a "training set" process. It's a medical device (infusion pump) whose performance is established through traditional engineering and clinical testing.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).